Tufts University Office of the Vice Provost
Social, Behavioral, and Educational Research Institutional Review Board (SBER IRB)
INVESTIGATOR RESPONSIBILITIES
Investigators who are conducting research using human participants have the following responsibilities:
General Responsibilities:
- To comply with the Code of Federal Regulations regarding the protection of human subjects
- To protect the rights and welfare of all human subjects and to conduct all research according the IRBapproved protocol.
- To retain all data and signed consent documents for at least 3 years beyond the completion of the research.
Consent Responsibilities:
- To ensure that each potential participant understands the nature of the research.
- To ensure that the correct procedures are followed to gaininformed consent from each person prior to participation.
- To provide each participant with a copy of the IRB approved consent document unless waived by the IRB.
Educational Responsibilities:
- To ensure that all researchers, research assistants and faculty advisors have completed the required CITI training and that the certification is current. Certification is valid for a period of 5 years.
Procedural Responsibilities:
- When submitting to the SBER IRB, be sure to only use the most updated version of the required forms. They will always be posted on the website under ‘forms’.
- To not initiate any changes to the protocol without IRB review and approval, unless it is necessary to eliminate an immediate hazard.Submit the Request for Protocol Modification form.
- To submit to the IRB for continuing review (Request for Continuing Review Form) at least 6 weeks prior to the expiration date of the protocol if the research is going to continue past the expiration date.
- To promptly report any unanticipated problems to the IRB. Submit Unanticipated Problem Report form.
- To promptly report any adverse events to the IRB. Submit the Adverse Event Report form.
- To officially close the study once completed. Submit the Request for Study Closure form.
Tufts University Office of the Vice Provost
Social, Behavioral, and Educational Research Institutional Review Board (SBER IRB)
Faculty AdvisorResponsibilities
All faculty advisors’ who oversee undergraduate and graduate student research have the following responsibilities:
- To ensure that the principal investigator and additional research staff abide by the Investigator Responsibilities.
- To meet with the principal investigator to monitor study progress and ensure that the procedures outlined in the IRB protocol are followed.
- To be available to the principal investigator to supervise and address problems should they arise.
- To arrange for an alternate faculty advisor to assume these duties when unavailable (vacation or sabbatical).
- To oversee the prompt reporting of any adverse events or unanticipated problems to the IRB.
Please refer to the website for additional information:
Feel free to contact us at or 617-627-3417 for any assistance.
Revised May 2009